NCT03484104

Brief Summary

Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

March 16, 2018

Last Update Submit

September 27, 2021

Conditions

Cerebrovascular Circulation

Keywords

Cardiopulmonary bypassHypothermic circulatory arrestAortic arch surgery

Outcome Measures

Primary Outcomes (1)

  • TOI

    The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Vmca

    through study completion, an average of 1 year

  • Neurologic accidents

    through study completion, an average of 1 year

Study Arms (1)

Hypothermic circulatory arrest

Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion

Diagnostic Test: Measurement of tissue oxygenation index (TOI)

Interventions

Measurement of tissue oxygenation index (TOI)DIAGNOSTIC_TEST

TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest

Also known as: Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)
Hypothermic circulatory arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population scheduled for elective aortic arch surgery.

You may qualify if:

  • Age 18 years or older
  • Elective cardiac surgery with cardiopulmonary bypass
  • Hypothermic circulatory arrest
  • General informed consent signed

You may not qualify if:

  • \- Severe stenotis in cerebral arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inselspital, University Hospital Bern, University of Bern

Bern, 3010, Switzerland

Location

University of Bern

Bern, 3010, Switzerland

Location

Study Officials

  • Gabor Erdoes, MD PhD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 30, 2018

Study Start

July 1, 2018

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)